Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor

NCT03520205 | Completed

• 1 other identifier: IndonesiaUAnes021
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor

Conditions

Renal Transplant Donor of Left Kidney

Keywords

stress response; kidney donor; Cellular Imunological Function; quadratus lumborum block; numerical rating scale; morphine patient controlled analgesia

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation

  Measure by ELISA

  Before procedure, at the end of surgery, and 24 hours after abdominal insufflation

• Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative

  Cumulative morphine consumption at each time point in 24 hours after surgery

  2 hours, 6 hours, 12 hours, 24 hours.

Secondary Outcomes (14)

• Change from Baseline Patient Controlled Analgesia at 2, 6, 12 and 24 hours after procedure

  2, 6, 12, and 24 hours after procedure

• Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure

  2, 6, 12, and 24 hours after procedure

• Change from Baseline Blood Glucose at 2 hours after abdominal insufflation

  Before procedure and 2 hours after abdominal insufflation

• Change from Baseline Blood pressure

  Intraoperative and 24 hours

• Change from Baseline Mean Arterial Pressure

  Intraoperative and 24 hours

Study Arms (2)

Quadratus Lumborum Block

ACTIVE COMPARATOR

Patient will receive quadratus lumborum block

Procedure: Quadratus Lumborum Block

Continuous Epidural

ACTIVE COMPARATOR

Patient will receive epidural anesthesia

Procedure: Continuous Epidural

Interventions

Quadratus Lumborum Block PROCEDURE

Bilateral block using ultrasound will be performed before surgery and after surgery on patient using Stimuplex 100mm needle with Bupivacaine 0.25% 0.4 mL/kg, maximum dose 25 mL each side under general anaesthesia

Quadratus Lumborum Block

Continuous Epidural PROCEDURE

Patient will be given 6 mL/hour of Bupivacaine 0.25% for intraoperative analgesia and continued epidural 6 mL/hour Bupivacaine 0,125% as postoperative analgesia in 24 hours.

Continuous Epidural

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Kidney donor patients undergoing laparoscopic nephrectomy
• Body mass index below 30
• Duration of surgery 4 to 6 hours
• Patients who agreed to participate in this study and sign informed consent.

You may not qualify if:

• Have contraindication for quadratus lumborum block
• Have contraindication for epidural
• Previous history of local anesthetic drug allergy
• inability to communicate

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (15)

• Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.

  PMID: 23150820 BACKGROUND

• SarinKapoor H, Kaur R, Kaur H. Anaesthesia for renal transplant surgery. Acta Anaesthesiol Scand. 2007 Nov;51(10):1354-67. doi: 10.1111/j.1399-6576.2007.01447.x.

  PMID: 17944639 BACKGROUND

• Minnee RC, Idu MM. Laparoscopic donor nephrectomy. Neth J Med. 2010 May;68(5):199-206.

  PMID: 20508268 BACKGROUND

• Buunen M, Gholghesaei M, Veldkamp R, Meijer DW, Bonjer HJ, Bouvy ND. Stress response to laparoscopic surgery: a review. Surg Endosc. 2004 Jul;18(7):1022-8. doi: 10.1007/s00464-003-9169-7. Epub 2004 May 12.

  PMID: 15136930 BACKGROUND

• Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.

  PMID: 10927999 BACKGROUND

• Das W, Bhattacharya S, Ghosh S, Saha S, Mallik S, Pal S. Comparison between general anesthesia and spinal anesthesia in attenuation of stress response in laparoscopic cholecystectomy: A randomized prospective trial. Saudi J Anaesth. 2015 Apr-Jun;9(2):184-8. doi: 10.4103/1658-354X.152881.

  PMID: 25829908 BACKGROUND

• Gulyam Kuruba SM, Mukhtar K, Singh SK. A randomised controlled trial of ultrasound-guided transversus abdominis plane block for renal transplantation. Anaesthesia. 2014 Nov;69(11):1222-6. doi: 10.1111/anae.12704. Epub 2014 Jun 28.

  PMID: 24974901 BACKGROUND

• Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.

  PMID: 28154824 BACKGROUND

• Skrekas G, Papalois VE, Mitsis M, Hakim NS. Laparoscopic live donor nephrectomy: a step forward in kidney transplantation? JSLS. 2003 Jul-Sep;7(3):197-206.

  PMID: 14558706 BACKGROUND

• Oyen O, Scholz T, Hartmann A, Pfeffer P. Minimally invasive kidney transplantation: the first experience. Transplant Proc. 2006 Nov;38(9):2798-802. doi: 10.1016/j.transproceed.2006.08.102.

  PMID: 17112833 BACKGROUND

• Jianda X, Yuxing Q, Yi G, Hong Z, Libo P, Jianning Z. Impact of Preemptive Analgesia on inflammatory responses and Rehabilitation after Primary Total Knee Arthroplasty: A Controlled Clinical Study. Sci Rep. 2016 Aug 31;6:30354. doi: 10.1038/srep30354.

  PMID: 27578313 BACKGROUND

• Southworth SR, Woodward EJ, Peng A, Rock AD. An integrated safety analysis of intravenous ibuprofen (Caldolor((R))) in adults. J Pain Res. 2015 Oct 23;8:753-65. doi: 10.2147/JPR.S93547. eCollection 2015.

  PMID: 26604816 BACKGROUND

• Spiro MD, Eilers H. Intraoperative care of the transplant patient. Anesthesiol Clin. 2013 Dec;31(4):705-21. doi: 10.1016/j.anclin.2013.09.005. Epub 2013 Nov 6.

  PMID: 24287348 BACKGROUND

• Bhosale G, Shah V. Combined spinal-epidural anesthesia for renal transplantation. Transplant Proc. 2008 May;40(4):1122-4. doi: 10.1016/j.transproceed.2008.03.027.

  PMID: 18555130 BACKGROUND

• Aditianingsih D, Pryambodho, Anasy N, Tantri AR, Mochtar CA. A randomized controlled trial on analgesic effect of repeated Quadratus Lumborum block versus continuous epidural analgesia following laparoscopic nephrectomy. BMC Anesthesiol. 2019 Dec 5;19(1):221. doi: 10.1186/s12871-019-0891-7.

  PMID: 31805855 DERIVED

Related Links

• STRESS RESPONSE AND ANAESTHESIA ALTERING THE PERI AND POST-OPERATIVE MANAGEMENT
• Efficacy of parecoxib on the level of IL-6, CRP, and postoperative pain relief after percutaneous nephrolithotomy

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist Consultant

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: May 9, 2018
• Study Start: May 1, 2018
• Primary Completion: October 30, 2018
• Study Completion: December 31, 2018
• Last Updated: October 22, 2019

Record last verified: 2019-10

Locations

ID (1)